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OpenTrials
Completed

NCT Number: NCT03962257

The Use of an Online Learning and Consent Platform in Infertility Treatment

The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online library of interactive videos, compared to the traditional process of consent and one-on-one teaching using a 15 question evaluation. The secondary outcome will be to qualitatively assess patients' overall experience of the teaching process comparing the addition of the EngagedMD content to solely traditional teaching for infertility treatment.

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility CARE: The IVF Center, Winter Park, Florida, United States

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About this study

Participants: This will be a multi-center trial with each center planning on recruiting 100 couples. Half of the couples will be planning on undergoing ovulation induction with insemination (OI/IUI) and the other half in-vitro fertilization (IVF).

Procedures (methods): This is a multi-center prospective randomized controlled trial where couples undergoing OI/IUI or IVF will be randomized to receiving the current traditional standard of in-person treatment teaching by their physician and nursing team with standard paper consents or to the identical process of in-person teaching with the addition of unrestricted access to the EngagedMD online video resource platform with online consents.

Patient demographics, knowledge base, psychological impact of with the treatment, teaching and the consent process and overall satisfaction with the process as a whole will be assessed using surveys administered at three time points throughout the treatment process. A subset of patients that agree will be contacted after the completion of the treatment cycle for a live phone interview.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female subjects must be 18-49 years of age undergoing fertility treatment
  • Able to give Informed Consent

Exclusion criteria

  • Patients who do not have adequate command of the English language to provide informed consent

Treatment and study plan

EngagedMD online learning platform

Other

The EngagedMD online learning platform is a compilation of learning modules and questions designed to give patients at-home access to visual and audio aids in infertility treatment. It also gives patients the ability to read and sign consents from home.

Primary outcomes

  1. Patient understanding

    Time frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.

    Patient understanding of infertility diagnoses and treatment by use of a pre and post test. The test comprises of 15 multiple choice questions and the patients will receive a score of 0-15 and this will be compared as a paired continuous variable from the pre-test score to their post-test score as well as an un-paired continuous variable between the conventional group and the EngagedMD group for pre- and post-test scores as well as delta scores between the two.

Secondary outcomes

  1. Patient satisfaction

    Time frame: Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.

    Patient satisfaction with their infertility treatment and consent processes will be assessed using questionnaires using a 5 point Likert scale progressing from very unsatisfied to very satisfied across a number of questions. The 5 point Likert questions will be assigned a value of 1-5 (with 1 being very unsatisfied and 5 being very satisfied) and will be assessed as a sum of points from the individual questions and compared as continuous variables between the conventional arm and the EngagedMD arm. There is an additional question asking patients to rank their satisfaction on a scale of 1-10 (with 1 being not satisfied at all and 10 being extremely satisfied) which will be used independently as a measure of patient satisfaction overall.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Improving the Informed Consent Process for Infertile Patients Undergoing Assisted Reproductive Technology (ART) With EngagedMD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 24, 2019
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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